NCT00958841 · REGISTRY CONDITION SEARCH

Study of Pasireotide in Patients With Rare Tumors of Neuroendocrine Origin

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: TERMINATED
Registry last update: 2016-07-26

This study will assess the effectiveness and safety of pasireotide long-acting release in patients who have rare tumors of neuroendocrine origin.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Percentage of Responders at Month 6 - Pooled Pancreatic NETs (PNETs)

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outcome · POSTED

Percentage of Responders at Month 6 - Individual NETs

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outcome · POSTED

Percentage of Responders With Probability of Success at Month 6 - Individual NETs

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outcome · POSTED

PNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker

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outcome · POSTED

PiNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker

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outcome · POSTED

Nelson's Syndrome: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Male and Female Patients at least 18 years old * Patient who have rare tumors of neuroendocrine origin, such as tumors of the: 1. pancreas 2. pituitary glands 3. Nelson syndrome 4. ectopic-ACTH secreting tumor * Patients who have failed standard of care treatment or for whom no standard of care treatment exist * Signed Informed Consent Exclusion Criteria: * Patients with active gallbladder disease * Patients with any ongoing or planned anti-neoplastic or interferon therapy * Poorly controlled diabetes mellitus * Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control Other protocol-defined inclusion/exclusion criteria may apply.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.
intervention Names
Drug: pasireotide LAR
label
pasireotide LAR 60mg
type
EXPERIMENTAL

interventions

arm Group Labels
pasireotide LAR 60mg
description
Investigational drug pasireotide LAR was supplied in vials with 20 mg or 40 mg powder and 2 mL vehicle was supplied in ampoules for reconstitution.
name
pasireotide LAR
other Names
SOM230
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 118
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
The primary efficacy endpoint was defined as the percentage of responders at Month 6 among pooled PNET patients (insulinoma, gastrinoma, VIPoma, and glucagonoma). A responder was defined as a patient who either attained normalization or had a greater than 50% reduction from baseline of the level of the primary biochemical tumor marker at Month 6 (M6). Four insulinoma pts were excluded from analysis because of unavailability of normal ranges for the associated primary biochemical tumor marker (insulin-to-glucose ratio). One patient with VIPoma with a normal baseline was also excluded. As a result, only 20 out of 25 patients with PNET were included in the assessment of the primary endpoint, which was less than the planned sample size of 34. Therefore, the primary objective could not be assessed with sufficient power. Patients with missing Month 6 assessment were considered as non-responders. Responder analyses are reported only for indications with minimum of 6 patients.
measure
Percentage of Responders at Month 6 - Pooled Pancreatic NETs (PNETs)
time Frame
6 months

secondary Outcomes

description
Percentage of responders for each of the 10 NET indications considered in the study. Responder analyses were performed for an indication only if there were at least 6 patients in the efficacy analyzable set. For all other individual indications, the numbers of patients in the efficacy analyzable sets were less than 6 and therefore no responder analyses were carried out for these indications.
measure
Percentage of Responders at Month 6 - Individual NETs
time Frame
6 months
description
Percentage of responders for each of the 10 NET indications considered in the study. Responder analyses were performed for an indication only if there were at least 6 patients in the efficacy analyzable set. For all other individual indications, the numbers of patients in the efficacy analyzable sets were less than 6 and therefore no responder analyses were carried out for these indications. The probability of success was a chance that the true responder rate was greater than 15%) for the indications gastrinoma, prolactinoma, and Nelson's syndrome.
measure
Percentage of Responders With Probability of Success at Month 6 - Individual NETs
time Frame
6 months
description
Specific primary biochemical tumor markers were used to assess the efficacy of pasireotide in PNETs. A Month 6 responder was defined as the patients who either attained normalization or greater than 50% reduction from baseline in the level of the primary biochemical tumor marker at Month 6. One gastrinoma patient had a missing primary tumor marker value at Month 6, but had a Month 5 assessment done on Day 141, which fell within the allowed window period for Month 6.
measure
PNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker
time Frame
Baseline, month 6
description
Specific primary biochemical tumor markers were used to assess the efficacy of pasireotide in PNETs. A Month 6 responder was defined as the patients who either attained normalization or greater than 50% reduction from baseline in the level of the primary biochemical tumor marker at Month 6.
measure
PiNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker
time Frame
Baseline, month 6
description
Six patients with Nelson's syndrome met the responder's criteria of attaining normalization or a reduction of more than 50% in primary tumor marker at Month 6.
measure
Nelson's Syndrome: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker
time Frame
Baseline, month 6

Full study description

brief Summary: This study will assess the effectiveness and safety of pasireotide long-acting release in patients who have rare tumors of neuroendocrine origin.

Source references

Source notices and limitations

Discovery and provenance

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ctgov-registry-1336d216cbd1bbff780dac70
edge id
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requested nct id
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primary nct id
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source kind
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source url
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payload
clinical indication matching status
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id
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link basis
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nct id
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occurrences
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end
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exact text
NCT00958841
start
0
offset unit
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query cond
Pituitary Tumors
query disease state id
ds-pituitary-tumors
source file
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source json pointer
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source kind
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source record id
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source string basis
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source string sha256
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source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Pituitary+Tumors&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice